FDA.reportPublic FDA data

VITROS

Primary DI
10758750000203
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
1896836
Catalog number
1896836
Device description
VITROS Immunodiagnostic Products CK-MB Reagent Pack
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JHXFLUOROMETRIC METHOD, CPK OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHXFluorometric Method, Cpk Or IsoenzymesClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750000200PackageGS130In Commercial Distribution
10758750000203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000020020758750000200
1075875000020310758750000203

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22
10758750034413VITROS619996061999602021-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590781521Access CK-MBBeckman Coulter, Inc.JHX2024-03-01
10758750034314VITROSORTHO CLINICAL DIAGNOSTICSJHX2022-10-24
00380740174941AlinityAbbott Ireland DiagnosticsJHX2019-11-11
00380740174927AlinityAbbott Ireland DiagnosticsJHX2019-06-07
30014613337157TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337164TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337928TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337942TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.JHX2018-11-01
00845275002348Thermo Scientific Fisher DiagnosticsJHX2017-06-22
14858218671006Test2 Release 1.6.3Booz Allen Hamilton Inc.JHX2017-05-05
14858218671008Test2 Release 1.6.3Booz Allen Hamilton Inc.JHX2017-05-05
14858218671009Test2 Release 1.6.3Booz Allen Hamilton Inc.JHX2017-05-05
00893038002807Alere Triage®Alere San Diego, Inc.JHX2016-09-26
00899722002719Alere Triage®Alere San Diego, Inc.JHX2016-09-26
00899722002740Alere Triage®Alere San Diego, Inc.JHX2016-09-26
00899722002795Alere Triage®Alere San Diego, Inc.JHX2016-09-26
14560189210728ST AIA-PACK CK-MBTOSOH CORPORATIONJHX2016-09-24
04560189211674AIA-PACK CK-MB Calibrator SetTOSOH CORPORATIONJHX2016-09-24
04560189211681AIA-PACK CK-MB Sample Diluting SolutionTOSOH CORPORATIONJHX2016-09-24
00842768004438Stratus® CS STAT Fluorometric Analyzer CannulaSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004445Stratus® CS STAT Fluorometric Analyzer CannulaSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004469Stratus® CS Acute Care™ CCRP TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004476Stratus CS Acute Care CCRP CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004490Stratus® CS Acute Care™ CKMB TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004506Stratus® CS Acute Care™ CKMB CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004513Stratus® CS Acute Care™ CKMB DilPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004520Stratus® CS Acute Care™ cTNI TestPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24
00842768004537Stratus® CS Acute Care™ cTNI CalPakSiemens Healthcare Diagnostics Inc.JHX2016-09-24